Caldera Medical Principal Mechanical Engineer in Agoura Hills, California

Principal Mechanical Engineer

Caldera Medical’s Mission - To Improve the Quality of Life for Women!

Position Summary: The Principal Mechanical Engineer will lead mechanical design and development of innovative life-changing medical devices.

Responsibilities:

• Develop innovative products from early concepts to market introduction • Mechanical design of complex medical devices, instruments and systems • Provide technical leadership and mentorship during product development projects • Create detailed designs, drawings, tolerance analyses and quality requirements • Generate designs of experiments and prototypes to identify innovation solutions • Understand clinical needs and translate into quantifiable design requirements • Conduct design review, risk assessment and project documentation • Support design verification and validation activities • Participate in manufacturing process development, fixtures and test plans • Work with suppliers, manufacturers and industry experts to resolve project issues • Review and support compliance to regulatory requirements

Minimum Qualifications:

• Bachelor of Science in Mechanical Engineering • Minimum 10 years of experience in mechanical design of complex systems • At least 5 years of professional experience in development of medical devices • Expert in Solidworks, GD&T, engineering standards, tolerancing • Deep understanding of manufacturing processes, test methods and materials

Preferred qualification:

• Master’s in Mechanical Engineering, Biomedical Engineering or equivalent • Knowledge of modeling, analysis, simulation and prototyping tools • Experience designing electromechanical devices and electronic packaging • Knowledge of medical device regulatory standards and submission procedures • Familiarity with FMEA, risk analysis, quality systems and design controls • Ability to plan, set up and run tests for research and product verification • Positive thinking, energetic with team-building and leadership skills

About Caldera Medical:

Caldera Medical is a growth stage medical device company focused on designing, manufacturing, and marketing products into the Gynecology, Urology and Urogynecology surgical markets. We are searching for highly motivated, dynamic and results oriented individuals to join us in improving the quality of the patients we serve.

The Culture:

• A Culture of family and team…not a corporate goliath where you’re just another number • All employees get a seat at the table and have influence with management • Women’s Health Initiative - Giving back to those who can’t afford treatment ◦ Goal to treat 1 million women suffering from incontinence by 2025!

The Benefits:

• Competitive Compensation • Basic Life and AD&D • Unlimited Vacation • 6 Weeks Paid Maternity Leave Supplement • Being surrounded by talented and engaged employees • Medical / Dental Benefits – 75% paid for employee and family members • 401(k) with 4% matching contributions

Learn more about us on Glassdoor - https://www.glassdoor.com/Reviews/Caldera-Medical-Reviews-E356568.htm

Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.